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EP4299081B1 - Applikatoren zum aufbringen von transkutanen analytsensoren - Google Patents

Applikatoren zum aufbringen von transkutanen analytsensoren

Info

Publication number
EP4299081B1
EP4299081B1 EP23196361.2A EP23196361A EP4299081B1 EP 4299081 B1 EP4299081 B1 EP 4299081B1 EP 23196361 A EP23196361 A EP 23196361A EP 4299081 B1 EP4299081 B1 EP 4299081B1
Authority
EP
European Patent Office
Prior art keywords
applicator
housing
skin
assembly
actuation member
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP23196361.2A
Other languages
English (en)
French (fr)
Other versions
EP4299081A2 (de
EP4299081A3 (de
Inventor
Joseph J. BAKER
Phillip Thomas Pupa
Timothy Joseph Goldsmith
Jon BODNAR
Jason HALAC
John Michael Gray
Neal Davis Johnston
Justen Deering ENGLAND
Peter C. Simpson
Paul V. Neale
Jennifer Blackwell
Maria Noel Brown Wells
Kenneth PIRONDINI
Andrew Michael Reinhardt
Mark Douglas Kempkey
Young Woo Lee
Warren Terry
Patrick John CASTAGNA
David A. Keller
Randall Scott Koplin
Andrew JONCICH
Nirav BHATT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dexcom Inc
Original Assignee
Dexcom Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dexcom Inc filed Critical Dexcom Inc
Priority to EP25190748.1A priority Critical patent/EP4647086A3/de
Publication of EP4299081A2 publication Critical patent/EP4299081A2/de
Publication of EP4299081A3 publication Critical patent/EP4299081A3/de
Application granted granted Critical
Publication of EP4299081B1 publication Critical patent/EP4299081B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A61B5/6849—Needles in combination with a needle set
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06—Accessories for medical measuring apparatus
    • A61B2560/063—Devices specially adapted for delivering implantable medical measuring apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/24—Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
    • A61B2562/242—Packaging, i.e. for packaging the sensor or apparatus before use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/688—Means for maintaining contact with the body using adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/18—Aseptic storing means
    • A61L2202/182—Rigid packaging means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

  • An applicator for applying an on-skin assembly to skin of a host and methods of their use and/or manufacture are provided. More particularly, apparatuses for applying a transcutaneous analyte assembly to skin of a host for accurately measuring blood glucose of the host and methods of their use and/or manufacture are provided.
  • Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent).
  • Type I or insulin dependent in which the pancreas cannot create sufficient insulin
  • Type 2 or non-insulin dependent in which insulin is not effective
  • a hypoglycemic reaction low blood sugar
  • SMBG self-monitoring blood glucose
  • a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are spread so far apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects.
  • Glucose levels may be alternatively monitored continuously by a sensor system including an on-skin sensor assembly.
  • the sensor system may have a wireless transmitter which transmits measurement data to a receiver which can process and display information based on the measurements.
  • the present apparatuses and methods of manufacture relate to systems and methods for measuring an analyte in a host, systems and methods for manufacturing a transcutaneous analyte measurement system, and systems and methods for applying a transcutaneous analyte measurement system to skin of a host.
  • the various embodiments of the present systems and methods have several features, no single one of which is solely responsible for their desirable attributes. Without limiting the scope of the present embodiments as expressed by the claims that follow, their more prominent features now will be discussed briefly. After considering this discussion, and particularly after reading the section entitled "Detailed Description,” one will understand how the features of the present embodiments provide the advantages described herein.
  • an applicator for applying an on-skin assembly to skin of a host includes an insertion assembly configured to insert at least a portion of the sensor assembly into the skin of the host.
  • the applicator includes a housing configured to house the insertion assembly.
  • the housing includes an aperture through which the sensor assembly is configured to pass.
  • the applicator includes an actuation member configured to, upon activation, cause the insertion assembly to insert at least the portion of the sensor assembly into the skin of the host.
  • the applicator includes a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment of the housing and an external environment of the housing.
  • the applicator further includes one or more ridges or recesses configured to provide a tactile indication of grip for the host. In some embodiments, the applicator has a cross-sectional shape configured to provide a tactile indication of grip for the host. In some embodiments, the applicator further includes at least one protrusion configured to inhibit rolling of the applicator.
  • the housing comprises a vent configured to be permeable to a sterilizing gas.
  • the sealing element is configured to seal the vent. In some embodiments, the sealing element is configured to seal both the aperture and the actuation member. In some embodiments, the actuation member comprises a material that is permeable to a sterilizing gas.
  • the sealing element comprises a removable cap configured to couple with a portion of the housing.
  • the removable cap is configured to couple with a proximal portion of the housing.
  • the removable cap is configured to couple with a distal portion of the housing.
  • the removable cap is configured to couple with the housing in a single axial orientation.
  • the removable cap is configured to couple with the portion of the housing via threads.
  • the removable cap is configured to couple with the portion of the housing via a frangible member.
  • the frangible member is configured to provide a tamper indication when broken.
  • the sealing element further comprises an o-ring configured to provide a seal between the removable cap and the housing.
  • the removable cap covers the actuation member.
  • the insertion assembly is driven by a spring force.
  • the needle is retracted from the insertion assembly after the insertion assembly inserts the on-skin assembly.
  • the applicator further includes a safety member configured to prevent activation of the actuation member.
  • the safety member comprises a frangible member, the frangible member being configured to prevent activation of the actuation member, at least until the frangible member is broken.
  • sealing the internal environment of the housing from an external environment of the housing is performed simultaneously for a plurality of applicators.
  • sealing the internal environment of the housing from an external environment of the housing comprises subjecting the plurality of applicators to a partial vacuum exceeding a threshold such that a sealing element of each of the plurality of applicators transitions from being permeable to the sterilizing gas to being impermeable to the sterilizing gas.
  • sealing the internal environment of the housing from an external environment of the housing comprises subjecting the plurality of applicators to a physical force sufficient to cause a sealing element of each of the plurality of applicators to transition from a first physical configuration permeable to the sterilizing gas to a second physical configuration impermeable to the sterilizing gas.
  • sealing the internal environment of the housing from an external environment of the housing comprises subjecting a sealing element, comprising a plurality of perforations, of each the plurality of applicators to a temperature sufficient to at least partially melt each of the sealing elements thereby sealing the plurality of perforations in each of the sealing elements.
  • sealing the internal environment of the housing from an external environment of the housing comprises subjecting a sealing element, comprising a porous polymeric component, of each of the plurality of applicators to a temperature sufficient to form a sintered layer in the porous polymeric component of each sealing element.
  • sealing the internal environment of the housing from an external environment of the housing comprises depositing a layer impermeable to the sterilizing gas on at least a portion of each of the plurality of applicators.
  • the layer comprises at least one of aluminum oxide, parylene, a vapor metallization, silicon dioxide, or a material applied via ion beam sputtering.
  • an applicator for applying an on-skin assembly to skin of a host may include an insertion assembly configured to insert at least a portion of the on-skin assembly into the skin of the host.
  • the housing may be configured to receive the insertion assembly.
  • the housing may comprise an aperture through which the on-skin assembly is configured to pass.
  • the applicator may comprise an actuation member configured to, upon activation, actuate the insertion assembly to insert at least the portion of the on-skin assembly into the skin of the host.
  • the applicator may comprise a removable cap configured to couple with a portion of the housing.
  • the applicator may comprise a layer comprising a gas permeable material, the sealing element configured to allow for ingress and egress of a sterilizing gas.
  • the removable cap includes an aperture located at a bottom end of the removable cap.
  • the layer is coupled to the bottom of the removable cap and encloses the aperture.
  • the removable cap may include a raised platform from the bottom end of the removable cap.
  • the raised platform is spaced a predetermined distance from the on-skin assembly.
  • the raised platform may include a plurality of channels. The plurality of channels may be spaced equidistantly along the circumference of the raised platform. The plurality of channels may be configured to allow for ingress of the sterilizing gas into the housing and egress of the sterilizing gas out of the housing.
  • the applicator includes a safety feature to prevent actuation of the actuation member.
  • the safety feature can be unlocked by pressing the housing in a distal direction. The pressing of the housing in a distal direction actuates the housing along an inner housing of the applicator.
  • the actuation member may be aligned with a trigger arm, the actuation member configured to laterally actuate and deflect the trigger arm.
  • the removable cap is configured to couple with a proximal portion of the housing. In some embodiments, the removable cap is configured to couple with a distal portion of the housing.
  • the present application is directed to embodiments of applicators for applying an on-skin assembly to skin of a host as well as methods of their manufacture and use.
  • applicators for applying an on-skin assembly to skin of a host as well as methods of their manufacture and use.
  • certain features of the described applicators provide novel and inventive solutions to difficulties associated with previous applicator designs and/or methods of their use or manufacture.
  • FIG. 31 is a schematic of a continuous analyte sensor system 3100 attached to a host (e.g., a person).
  • the analyte sensor system 3100 communicates with other devices 3108-3114 (which can be located remotely from the host).
  • a transcutaneous analyte sensor system 3100 comprising an on-skin sensor assembly 3106 is fastened to the skin of a host via a base (not shown), which can be a disposable housing.
  • One or more repeaters, receivers and/or display devices such as a key fob repeater 3108, a medical device receiver 3110 (e.g., an insulin delivery device and/or a dedicated glucose sensor receiver), a smartphone 3112, a portable computer 3114, and the like can be communicatively coupled to the electronics unit 3104 (e.g., to receive data from the electronics unit 3104).
  • the electronics unit 3104 can also be referred to as a transmitter.
  • the devices 3108-3114 transmit data to the electronics unit 3104.
  • the sensor data can be transmitted from the sensor electronics unit 3104 to one or more of the key fob repeater 3108, the medical device receiver 3110, the smartphone 3112, the portable computer 3114, and the like.
  • analyte values are displayed on a display device.
  • analyte is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid, urine, sweat, saliva, etc.) that can be analyzed.
  • a biological fluid for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid, urine, sweat, saliva, etc.
  • Analytes can include naturally occurring substances, artificial substances, metabolites, or reaction products.
  • an adhesive can be to couple a base, a sensor module, and/or a sensor to a host (e.g., to skin of the host).
  • the adhesive can be configured for adhering to skin.
  • the adhesive can include a pad (e.g., that is located between the adhesive and the base). Additional adhesive information, including adhesive pad information, is described in U.S. Patent Application No. 14/835,603, which was filed on August 25, 2015 .
  • tamper evident sealing or other tamper evidence features may be desirable because such features allow a consumer to identify when an applicator has been previously used or containment has been breached and, thus, avoid using an applicator that may be faulty or pose an increased health risk if used. Examples of tamper evidence features are described in more detail in connection with at least some of FIGS. 1A-40 below.
  • FIG. 1A is an exploded, cutaway view of an applicator 100 for applying an on-skin assembly 102 to skin of a host including a sealing element 110, in accordance with some embodiments.
  • Applicator 100 comprises a housing 104 configured to house an insertion assembly 118 (see FIG. 1B ). Housing 104 comprises an aperture 106 through which on-skin assembly 102 (see FIG. 1B ) is configured to pass during deployment. The side of housing 104 may further comprise an opening 120 configured to receive an actuation member (not shown in FIGs. 1A-1C ).
  • Applicator 100 further comprises a sealing element 110 configured to provide a sterile barrier and/or a vapor barrier between an internal environment of housing 104 and an external environment of housing 104.
  • sealing element 110 comprises a removable cap 112 configured to couple with a portion of housing 104.
  • removable cap 112 is configured to couple with a distal portion of housing 104 via threads 114.
  • threads 114 disposed on removable cap 112 may be configured to mate with threads 108 disposed on housing 104.
  • telescoping assembly 132h of FIG. 60 telescoping assembly 132i of FIG. 48-50, telescoping assembly 132k of FIGS. 61-64, telescoping assembly 132m of FIGS. 71-74, telescoping assembly 132n of FIGS. 76-79, telescoping assembly 132p of FIGS. 80-85, telescoping assembly 132q of FIGS. 86-88, telescoping assembly 132r of FIGS. 89-91, telescoping assembly 132s of FIGS. 92-100, or telescoping assembly 132w of FIGS. 110-119, respectively described in U.S. Patent App. No. 15/387088 .
  • On-skin assembly 102 may be attached to the host with use of applicator 100 adapted to provide convenient and secure application. Applicator 100 may also be used for inserting at least a portion of on-skin assembly 102 through the host's skin. Once the portion of on-skin assembly 102 has been inserted, applicator 100 detaches from on-skin assembly 102.
  • sensor 132 is a continuous glucose sensor and comprises a subcutaneous sensor such as described with reference to U.S. Patent 6,579,690 to Bonnecaze et al. or U.S. Patent 6,484,046 to Say et al. , for example.
  • sensor 132 is a continuous glucose sensor and comprises a subcutaneous sensor such as described with reference to U.S. Patent 6,512,939 to Colvin et al.
  • sensor 132 is a continuous glucose sensor and comprises an intravascular sensor such as described with reference to U.S. Patent 6,477,395 to Schulman et al. , for example.
  • sensor 132 is a continuous glucose sensor and comprises an intravascular sensor such as described with reference to U.S. Patent 6,424,847 to Mastrototaro et al.
  • Other signal processing techniques and glucose monitoring system embodiments suitable for use with the embodiments described herein are described in U.S. Patent Publication No. US-2005-0203360-A1 and U.S. Patent Publication No. US-2009-0192745-A1 .
  • applicator 100 can be configured for use in applying a drug delivery device, such an infusion device, to the skin of a patient.
  • applicator 100 can include a catheter instead of, or in addition to, a sensor, the catheter being connected to an infusion pump configured to deliver liquid medicines or other fluids into the patient's body.
  • the catheter can be deployed into the skin in much the same manner as a sensor would be, for example as described herein.
  • sensor 132 is formed from a wire or is in a form of a wire.
  • sensor 132 can include an elongated conductive body, such as a bare elongated conductive core (e.g., a metal wire) or an elongated conductive core coated with one, two, three, four, five, or more layers of material, each of which may or may not be conductive.
  • the elongated sensor may be long and thin, yet flexible and strong.
  • a conductive wire electrode is employed as a core.
  • one or two additional conducting layers may be added (e.g., with intervening insulating layers provided for electrical isolation).
  • the conductive layers can be comprised of any suitable material.
  • the materials used to form the elongated conductive body can be strong and hard, and therefore are resistant to breakage.
  • the ultimate tensile strength of the elongated conductive body is from about 80 kPsi to about 500 kPsi (0.5516 GPa to about 3.447 GPa).
  • the Young's modulus of the elongated conductive body is from about 160 GPa to about 220 GPa.
  • the yield strength of the elongated conductive body is from about 60 kPsi to about 2200 kPsi (0.4137 GPa to about 15.17 GPa).
  • sensor's 132 small diameter provides (e.g., imparts, enables) flexibility to these materials, and therefore to sensor 132 as a whole. Thus, sensor 132 can withstand repeated forces applied to it by surrounding tissue.
  • the core (or a component thereof) provides electrical conduction for an electrical signal from the working electrode to sensor electronics (not shown).
  • the core comprises a conductive material, such as stainless steel, titanium, tantalum, a conductive polymer, and/or the like.
  • the core is formed from a non-conductive material, such as a non-conductive polymer.
  • the core comprises a plurality of layers of materials.
  • the core includes an inner core and an outer core.
  • the inner core is formed of a first conductive material and the outer core is formed of a second conductive material.
  • the first conductive material is stainless steel, titanium, tantalum, a conductive polymer, an alloy, and/or the like
  • the second conductive material is conductive material selected to provide electrical conduction between the core and the first layer, and/or to attach the first layer to the core (e.g., if the first layer is formed of a material that does not attach well to the core material).
  • the core is formed of a non-conductive material (e.g., a non-conductive metal and/or a non-conductive polymer) and the first layer is a conductive material, such as stainless steel, titanium, tantalum, a conductive polymer, and/or the like.
  • the core and the first layer can be of a single (or same) material, e.g., platinum.
  • transmitter 134 is incorporated into on-skin assembly 102, while in other embodiments, the transmitter 134 can be releasably coupled to the sensor.
  • Transmitter 134 includes electronic circuitry associated with measuring and processing the continuous analyte sensor data, and is configured to perform algorithms associated with processing and calibration of the sensor data.
  • transmitter 134 can provide various aspects of the functionality of a sensor electronics module as described in U.S. Patent Publication No. 2009-0240120-A1 and U.S. Patent Publication No. 2012-0078071-A1 .
  • Transmitter 134 may include hardware, firmware, and/or software that enable measurement of levels of the analyte via a glucose sensor, such as an analyte on-skin assembly 102.
  • transmitter 134 can include a potentiostat, a power source for providing power to on-skin assembly 102, other components useful for signal processing and data storage, and preferably a telemetry module for one- or two-way data communication between transmitter 134 and one or more receivers, repeaters, and/or display devices.
  • Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms.
  • the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor.
  • IC integrated circuit
  • ASIC Application-Specific Integrated Circuit
  • Transmitter 134 may include sensor electronics that are configured to process sensor information, such as storing data, analyzing data streams, calibrating analyte sensor data, estimating analyte values, comparing estimated analyte values with time corresponding measured analyte values, analyzing a variation of estimated analyte values, and the like. Examples of systems and methods for processing sensor analyte data are described in more detail herein and in U.S. Patent No. 7,310,544 , U.S. Patent No. 6,931,327 , U.S. Patent Publication No. 2005-0043598-A1 , U.S. Patent Publication No. 2007-0032706-A1 , U.S. Patent Publication No.
  • 2007-0016381-A1 U.S. Patent Publication No. 2008-0033254-A1 , U.S. Patent Publication No. 2005-0203360-A1 , U.S. Patent Publication No. 2005-0154271-A1 , U.S. Patent Publication No. 2005-0192557-A1 , U.S. Patent Publication No. 2006-0222566-A1 , U.S. Patent Publication No. 2007-0203966-A1 and U.S. Patent Publication No. 2007-0208245-A1 .
  • One or more repeaters, receivers and/or display devices such as a medical device receiver (e.g., insulin delivery device and/or dedicated glucose sensor receiver), smart phone, portable computer, and the like may be operatively linked to and receive data from transmitter 134, and in some embodiments transmit data to transmitter 134.
  • a medical device receiver e.g., insulin delivery device and/or dedicated glucose sensor receiver
  • smart phone e.g., smart phone, portable computer, and the like
  • analyte values are displayed on a display device.
  • prompts or messages can be displayed on the display device to convey information to the user, such as reference outlier values, requests for reference analyte values, therapy recommendations, deviation of the measured analyte values from the estimated analyte values, or the like. Additionally, prompts can be displayed to guide the user through calibration or trouble-shooting of the calibration.
  • any applicator described in this specification may include insertion assembly 118 and on-skin assembly 102 as described in connection with FIGs. 1A and 1B .
  • Applicator 100 may further comprise a tamper indicator 130, specifically, a tamper-evident ring configured to break away from removable cap 112 when removable cap 112 is twisted with respect to housing 104.
  • tamper indicator 130 may provide a safety feature for a host using applicator 100 such that if the tamper-evident ring is broken, tampering would be visually evident to a user.
  • FIG. 1C illustrates another applicator 150 for applying on-skin assembly 102 to skin of a host including a sealing element 160 having a frangible member 164, in accordance with some other embodiments.
  • Applicator 150 may comprise all features previously described in connection with applicator 100 of FIGs. 1A and 1B except, instead of utilizing threads 114 and 108, sealing element 160 comprises a removable cap 162 configured to couple with a distal portion of housing 104 via frangible member 164.
  • frangible member 164 comprises a loop and a circumferential frangible portion configured to be removed by pulling on the loop.
  • sealing element 160 including removable cap 162 and frangible member 164, may maintain sterilization and simultaneously provide a moisture seal for elements within housing 104.
  • Frangible member 164 may prevent sealing cap 162 from being removed without also removing frangible member 164.
  • Frangible member 164 further provides a tamper indicator and safety feature for a host using applicator 150 such that if the frangible member 164 is broken, tampering would be visually evident to a user.
  • FIG. 2A illustrates a perspective view of an applicator 200 for applying on-skin assembly 102 to skin of a host including a peelable tamper indicator 230, in accordance with some embodiments.
  • Applicator 200 may comprise all features previously described in connection with applicator 100 of FIGs. 1A and 1B except those specifically indicated as not being present below.
  • applicator 200 may further include at least insertion assembly 118 and on-skin assembly 102 as described in connection with FIGs. 1A-1C .
  • Applicator 200 comprises a housing 204, a sealing element 210 comprising a removable cap 212, and peelable tamper indicator 230.
  • Housing 204 may not include flexible wall 128 or threads 108 as previously described in connection with FIGs. 1A and 1B .
  • removable cap 212 may not include threads 114.
  • removable cap 212 may comprise at least one protrusion 220 or flattened (e.g., substantially planar) section configured to inhibit rolling of applicator 200 and to provide an orientation indicator for the user.
  • Removable cap 212 may be detached from housing 204 by peeling off peelable tamper indicator 230 and pulling apart removable cap 212 and housing 204. Thus, if peelable tamper indicator 230 has been disturbed, tampering would be visually evident to a user.
  • FIG. 2B is a partially exploded view of applicator 200 of FIG. 2A .
  • applicator 200 may further comprise an actuation member 250 (e.g., a push button) configured to, upon activation, cause insertion assembly 118 (see FIG. 1B ) to insert at least a portion of on-skin assembly 102 (see FIG. 1B ) into the skin of a host through aperture 106.
  • actuation member 250 e.g., a push button
  • removable cap 212 covers actuation member 250 by virtue of actuation member 250 being disposed on a side of housing 204 and removable cap 212 covering a distal portion of housing 204 which shrouds actuation member 250.
  • Sealing element 210 may further comprise first layer 122 and second layer 124, as previously described in connection with FIG. 1B .
  • First layer 222 and second layer 224 may be disposed over one or more openings 226 in the bottom of removable cap 212.
  • the one or more openings 226 facilitate in sterilization and/or venting of the applicator 200.
  • the above-described features of sealing element 210 may provide joint sterilization and moisture sealing for applicator 200.
  • FIG. 3A illustrates a perspective view of an applicator 300 for applying on-skin assembly 102 to skin of a host including a perforated tamper indicator tab 330, in accordance with some embodiments.
  • Applicator 300 may comprise all features previously described in connection with applicator 100 of FIGs. 1A and 1B except those specifically indicated as not being present below.
  • applicator 300 may further include at least insertion assembly 118 and on-skin assembly 102 as described in connection with FIGs. 1A-1C .
  • Applicator 300 comprises a housing 304, a sealing element 310 comprising at least a removable cap 312, and adhesive mounted tamper indicator tab 330.
  • Tamper indicator tab 330 may be adhesively backed paper, polymer, or other compatible film material. The tamper indicator tab 330 may further contain perforations, scoring, or deformed sections to guide removal of the tamper indicator tab 330.
  • Housing 304 is further shown to include optional flexible wall 128 but may not include threads 108 as previously described in connection with FIGs. 1A and 1B .
  • removable cap 312 may not include threads 114. Removable cap 312 may be detached from housing 304 by twisting and pulling apart removable cap 312 and housing 304. Any tampering with applicator 300 may result in the breaking of tamper indicator tab 330, providing visual evidence of tampering to a user.
  • FIG. 3B is a zoomed cutaway view of applicator 300 of FIG. 3A , in accordance with some embodiments.
  • removable cap 312 and/or housing 304 may comprise retention element 138 as previously described in connection with FIGs. 1A and 1B .
  • Sealing element 310 may further comprise an O-ring 340 configured to provide a seal between removable cap 312 and housing 304.
  • O-ring 340 may be integrally molded together with either cap 312 or housing 304.
  • FIG. 3C is another zoomed cutaway view of applicator 300 of FIGs. 3A and 3B , in accordance with some embodiments.
  • the side of housing 304 may further comprise opening 120 configured to receive an actuation member (not shown in FIGs. 3A-3C ), as previously described in connection with FIGs. 1A and 1B .
  • an actuation member By providing an actuation member on a side of housing 304, applicator 300 may provide for easy single-handed deployment of on-skin assembly 102 (not shown in FIG. 3C ) to the skin of a host.
  • FIG. 3C further illustrates opening 126 in the bottom of removable cap 312, as previously described in connection with FIGs. 1A and 1B .
  • sealing element 310 may further comprise first layer 122 and second layer 124 covering opening 126, as previously described in connection with FIGs. 1A and 1B . Together, the above-described features of sealing element 310 may provide joint sterilization and moisture sealing of applicator 100.
  • FIG. 4A illustrates another applicator 400 for applying on-skin assembly 102 to skin of a host including a tamper indicator tab 330, in accordance with some embodiments.
  • FIG. 4B is a partially exploded view of applicator 400 of FIG. 4A .
  • Applicator 400 comprises substantially similar features of applicator 200 of FIGs. 2A and 2B , however, replacing peelable tamper indicator 230 with tamper indicator tab 330 of FIGs. 3A-3C .
  • applicator 400 may comprise the one or more openings 226 in the bottom of removable cap 212, as previously described in connection with at least FIG. 2B .
  • First layer 122 and second layer 124 may cover the one or more openings 226.
  • FIG. 5A illustrates another applicator 500 for applying on-skin assembly 102 to skin of a host including a tactile indication of grip for the host, in accordance with some embodiments.
  • FIG. 5B is a partially exploded view of applicator 500 of FIG. 5A .
  • Applicator 500 comprises substantially all features of applicator 200 of FIGs. 2A and 2B , however, replacing peelable tamper indicator 230 with a tamper-evident twist-off collar 530 and further including at least one set of one or more ridges or recesses 542, 544 configured to provide a tactile indication of grip to the host.
  • FIGs. 5A and 5B show a housing 504, which may be substantially the same as housing 204 of FIGs.
  • FIGs. 5A and 5B f urther show a removable cap 512, which may be substantially the same as removable cap 212, however, further including a second set of one or more ridges or recesses 544 configured to provide a tactile indication of grip to the host.
  • applicator 500 may comprise the one or more openings 226 in the bottom of removable cap 212, as previously described in connection with at least FIG. 2B .
  • First layer 122 and second layer 124 may cover the one or more openings 226.
  • tamper-evident twist-off collar 530 may provide a seal (e.g., a sterile barrier and a moisture or water vapor barrier) between housing 504 and removable cap 512. In its separated state, tamper-evident twist-off collar 530 may provide an indication of tampering to a user.
  • a seal e.g., a sterile barrier and a moisture or water vapor barrier
  • FIGs. 6A and 6 B show housing 604, which may be substantially the same as housing 204 of FIGs. 2A and 2B , however, further including a first set of one or more ridges or recesses 642 configured to provide a tactile indication of grip to the host.
  • Housing 604 may also include a visual indicator 608 located on a surface of housing 604 (as shown located on the top surface).
  • Visual indicator 608 may be a slight protrusion or a slight indentation from the surface of the housing 604.
  • visual indicator 608 may have a shape similar to the shape of the on-skin assembly 102.
  • the orientation of visual indicator 608 may match with the orientation of on-skin assembly 102 within applicator 600. As such, visual indicator 608 may assist in orienting the user to the orientation of the on-skin assembly 102 within the applicator 600 prior to deployment.
  • Removable cap 612 may be detached from housing 604 by twisting removable cap 612 with respect to housing 604, or vice versa, and then pulling removable cap 612 and housing 604 apart.
  • the irregularly shaped mating edges 652, 654 of housing 604 and removable cap 612 also function as a tamper indication, since any tampering that causes relative displacement in any direction between removable cap 612 and housing 604 would cause their separation, thereby providing visual indication of tampering.
  • Applicator 700 further comprises an actuation member 750 comprising a telescoping cap coupled to the proximal portion of housing 704. Accordingly, sealing layer 764 is disposed between the actuation member 750 (i.e., the cap) and housing 704. Actuation member 750 is configured to be activated by moving the cap in a distal direction. Accordingly, actuation member 750 may further comprise a protrusion 752 configured to pierce sealing layer 764 and thereby activate insertion assembly 118 (not shown) within housing 704 when the cap is moved in the distal direction. In some embodiments, actuation member 750 may be spring loaded such that pressure exceeding a threshold is required in order to move the cap in the distal direction sufficiently to activate actuation member 750.
  • Applicator 700 may further comprise a frangible safety member 766 configured to prevent activation of actuation member 750.
  • frangible safety member 766 is disposed between actuation member 750 and a distal portion of housing 704 such that frangible safety member 766 physically prevents movement of actuation member 750 at least until frangible safety member 766 is removed or sufficiently displaced. In this way, frangible safety member 766 simultaneously provides a premature deployment feature, a drop protection feature, and a tamper indication.
  • FIG. 8A illustrates another applicator 800 for applying on-skin assembly 102 to skin of a host including another frangible safety member 866 configured to prevent activation of an actuation member 850, in accordance with some embodiments.
  • Applicator 800 is substantially the same as application 700 previously described in connection with FIGs. 7A and 7B , however, including a few similar features having slightly different shapes, excluding vent 764, and further illustrating a few additional features as described below.
  • Ingress and egress of a sterilizing gas may then be achieved through the opening in the proximal portion of housing 704, after which sealing layer 764 may be disposed over the opening and over the proximal portion of housing 704, thereby completely sealing an inside of housing 704 from an outside environment.
  • the combination of at least housing 704, second layer 124 and sealing layer 764 may form a sealing element configured to provide a sterile barrier and a vapor barrier between an internal environment and an external environment of housing 704.
  • FIG. 8B further illustrates protrusion 752 of actuation member 850 in a position ready to pierce sealing layer 764 when actuation member 850 (e.g., telescoping cap) is moved in a distal direction.
  • Applicator 800 is further illustrated as including a spring feature 854 (e.g. molded or integrated spring feature) configured to provide the biased force loaded aspect of the actuation member 850 as previously described in connection with FIGs. 7A and 7B .
  • a spring feature 854 e.g. molded or integrated spring feature
  • FIG. 8C is a cutaway view of applicator 800 of FIG. 8A in a deployed configuration. As shown, second layer 124 has been removed before deployment and actuation member 850 is shown as having been moved in the distal direction, causing protrusion 752 to pierce sealing layer 764 and activate insertion assembly 118.
  • FIG. 9A illustrates another applicator 900 for applying on-skin assembly 102 to skin of a host including an actuation member 950 configured as a cap disposed over housing 704 of applicator 900, in accordance with some embodiments.
  • Applicator 900 is substantially similar to applicator 800 previously described in connection with FIGs. 8A-8C , except as described below.
  • applicator 900 includes housing 704, second layer 124 sealing aperture 106 (not shown) of housing 704 and sealing layer 764 disposed on proximal portion of housing 704.
  • Applicator 900 further comprises actuation member 950 comprising a cap coupled to the proximal portion of housing 704.
  • applicator 900 may not include spring feature 854, but instead comprises a spring feature 954 disposed on a side of housing 704 between housing 704 and the cup of actuation member 950, which may provide substantially the same effect as spring feature 854.
  • spring feature 954 may be coupled to housing 704 at one end and coupled to the cup forming actuation member 950 at the other end.
  • Actuation member 950 may provide additional premature deployment prevention and drop protection features.
  • FIG. 9B further illustrates protrusion 752 of actuation member 950 in a position ready to pierce sealing layer 764 when actuation member 950 (e.g., telescoping cap) is moved in a distal direction.
  • Applicator 900 is further illustrated as including the spring feature 954 configured to provide the biased force loaded aspect of the actuation member 950 as previously described.
  • FIG. 9C is a cutaway view of applicator 900 of FIG. 9A in a deployed configuration. As shown, second layer 124 has been removed before deployment and actuation member 950 is shown as having been moved in the distal direction and side flexure 956 depressed, causing protrusion 752 to pierce sealing layer 764 and activate insertion assembly 118.
  • FIG. 10A illustrates another applicator 1000 for applying on-skin assembly 102 to skin of a host including a removable cap 1012 configured as a sealing element, in accordance with some embodiments.
  • FIG. 10B is a partially exploded view of applicator 1000 of FIG. 10A . Discussion of applicator 1000 will now take place with reference to both FIGs. 10A and 10B .
  • Applicator 1000 is substantially the same as applicator 700 of FIGs. 7A and 7B , except as described below.
  • Applicator 1000 comprises a housing 1004, which may function substantially the same as housing 704.
  • Applicator 1000 further comprises a telescoping cap 1050 that functions as an actuation member.
  • Applicator 1000 may not include second layer 124 or frangible safety member 766 of FIGs.
  • applicator 1000 may include a removable cap 1012 configured to couple with a distal portion of telescoping cap 1050 actuation member via threads 1014.
  • a layer 1052 permeable to a sterilizing gas e.g., Tyvek ®
  • Threads 1014 disposed on removable cap 1012 may be configured to mate with threads (not shown) disposed on an inside surface of the cap forming actuation member 1050.
  • Removable cap 1012 may be detached from actuation member 1050 by twisting removable cap 1012 with respect to telescoping cap 1050, or vice versa.
  • removable cap 1012 provides not only a sealing element configured to provide a sterile barrier and a vapor barrier between an internal and external environment of housing 1004, but also at least premature deployment prevention and drop protection features.
  • Applicator 1100 may further comprise an actuation member 1150 disposed on a side of housing 1104 and configured to, upon activation, cause insertion assembly 118 to insert at least a portion of on-skin assembly into the skin of a host.
  • Applicator 1100 may further comprise flexible member 1160 disposed over housing 1104.
  • Applicator 1100 may further comprise second layer 124, which may seal a distal portion of flexible member 1160.
  • second layer 124 in conjunction with flexible member 1160 provide a sealing element configured to provide a sterile barrier and a vapor barrier between an internal and external environment of housing 1104. As shown in FIG.
  • flexible member 1160 may comprise a flexible section 1162 configured to be disposed over actuation member 1150 such that when flexible section 1162 is pressed, actuation member 1150 is activated.
  • flexible section 1162 may be bistable in that it has two states: a first, loaded state and a second, deployed state. In such embodiments, flexible section 1162 may provide a positive visual tamper indication when in the second, deployed state.
  • the flexible nature of flexible member 1160 may additionally provide premature deployment prevention and drop protection features by absorbing energy that might otherwise provide a physical shock to applicator 1100.
  • FIG. 30A is a zoomed view of a sealing element comprising a vent 3062 including a material permeable to a sterilizing gas, in accordance with some embodiments.
  • the material may comprise a porous polymeric component such as Porex ® , although any material permeable to a sterilizing gas may be utilized.
  • the sealing element may be integral to a removable cap 3012, for example, as previously described in connection with any previous figure illustrating a removable cap.
  • One or more applicators utilizing the sealing element comprising vent 3062 may be subjected to a sterilizing gas, which may ingress and egress the applicators via vent 3062. Once sterilization is complete, the sealing element comprising vent 3062 may be subjected to a temperature sufficient to form a sintered layer 3063 (see FIG. 30B ) in the porous polymeric component of vent 3062.
  • FIG. 30B is a zoomed view of the sealing element of FIG. 30A illustrating sintered layer 3063 of vent 3062, which is impermeable to the sterilizing gas. Because the operative transforming method is application of heat sufficient to sinter the porous polymeric component of vent 3062, batch sterilization and/or vapor sealing of a plurality of applicators may be achieved simultaneously.
  • Flowchart 3200 further comprises block 3204, which includes providing a housing configured to receive the insertion assembly, the housing comprising an aperture through which the on-skin assembly can pass.
  • a housing may be as previously described in connection with any of FIGs. 1A-30 .
  • Flowchart 3200 further comprises block 3208, which includes providing a sealing element configured to provide a sterile barrier and/or a vapor barrier between an internal environment of the housing and an external environment of the housing.
  • a sealing element as previously described in connection with any of FIGs. 1A-30 may be provided.
  • such a sealing element may not necessarily comprise a single element but instead may comprise any combination of removable caps, with or without threads, first or second layers, sealing layers, peelable sealing layers, frangible members or caps, flexible members, O-rings, bags, or other seals, as previously described in connection with any combination from FIGs. 1A- 30.
  • FIG. 33 is a flowchart illustrating another method of manufacturing an applicator for applying on-skin assembly 102 to skin of a host, in accordance with some embodiments. Steps in flowchart 3300 may be performed for manufacturing any applicator as previously described in connection with any of the previous FIGs. Although certain steps are set forth below, a method of manufacturing such an applicator may comprise more, fewer, or different steps, in the same or different order from that set forth below. Moreover, in some embodiments, this method may be utilized to manufacture a plurality of applicators in batches.
  • Flowchart 3300 comprises block 3302, which includes providing an insertion assembly configured to insert at least a portion of the on-skin assembly into the skin of the host.
  • on-skin assembly 102 may be provided as previously described in connection with at least FIG. 1B .
  • Flowchart 3300 further comprises block 3304, which includes providing a housing configured to receive the insertion assembly, the housing comprising an aperture through which the on-skin assembly can pass.
  • a housing may be as previously described in connection with any of FIGs. 1A-30 .
  • Flowchart 3300 further comprises block 3308, which includes exposing at least an internal environment of the housing to a sterilizing gas.
  • a sterilizing gas such as ethylene oxide (ETO)
  • ETO ethylene oxide
  • a sealing element that transforms the housing from permeable to the sterilizing gas to impermeable to at least the sterilizing gas.
  • Flowchart 3300 further comprises block 3310, which includes allowing for egress of the sterilizing gas from the internal environment of the housing. For example, upon exposing the applicator to the sterilizing gas, the sterilizing gas may be removed and a sufficient amount of time may elapse before continuing the manufacturing process to allow for egress of substantially all sterilizing gas from the internal environment of the housing.
  • Flowchart 3300 further comprises block 3312, which includes sealing the internal environment of the housing from an external environment of the housing.
  • a sealing element as previously described in connection with any of FIGs. 1A-30 may be provided.
  • such a sealing element may not necessarily comprise a single element but instead may comprise any combination of removable caps, with or without threads, first or second layers, sealing layers, peelable sealing layers, frangible members or caps, flexible members, O-rings, bags, or other seals, as previously described in connection with any combination from FIGs. 1A- 30.
  • sealing the internal environment of the housing from an external environment of the housing is performed simultaneously for a plurality of applicators.
  • sealing the internal environment of the housing from an external environment of the housing comprises subjecting the plurality of applicators to a partial vacuum exceeding a threshold such that a sealing element of each of the plurality of applicators transitions from being permeable to the sterilizing gas to being impermeable to the sterilizing gas, as previously described in connection with at least FIGs . 27A and 27B .
  • sealing the internal environment of the housing from an external environment of the housing comprises subjecting a sealing element, comprising a plurality of perforations, of each the plurality of applicators to a temperature sufficient to at least partially melt each of the sealing elements thereby sealing the plurality of perforations in each of the sealing elements, as previously described in connection with FIGs. 26A and 26B .
  • sealing the internal environment of the housing from an external environment of the housing comprises subjecting a sealing element, comprising a porous polymeric component, of each of the plurality of applicators to a temperature sufficient to form a sintered layer in the porous polymeric component of each sealing element, as previously described in connection with FIGs. 30A and 30B .
  • sealing the internal environment of the housing from an external environment of the housing comprises depositing a layer impermeable to the sterilizing gas on at least a portion of each of the plurality of applicators, as previously described in connection with FIG. 29 .
  • the layer comprises at least one of a metallic foil (e.g. aluminum, titanium), a metallic substrate, aluminum oxide coated polymer, parylene, a polymer coated with a metal applied via vapor metallization, silicon dioxide coated polymer, or any material having a moisture vapor transmission rate less than 10 grams/100in 2 (155g/m 2 ) or preferably less than 1 grams/100in (15.5g/m 2 ).

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Claims (13)

  1. Applikator (100) zum Aufbringen einer Auf-der-Haut-Anordnung (102) auf die Haut eines Patienten, wobei der Applikator (100) umfasst:
    eine Einführanordnung (118), welche dazu konfiguriert ist, zumindest einen Abschnitt der Auf-der-Haut-Anordnung (102) in die Haut des Patienten einzuführen;
    ein Gehäuse (104), welches dazu konfiguriert ist, die Einführanordnung (118) aufzunehmen, wobei das Gehäuse (104) eine Öffnung (106) umfasst, durch welche die Auf-der-Haut-Anordnung (102) hindurchpasst;
    ein Betätigungselement, welches so konfiguriert ist, dass es bei Aktivierung die Einführanordnung (118) betätigt, um zumindest den Abschnitt der auf der Auf-der-Haut-Anordnung (102) in die Haut des Patienten einzuführen;
    ein Dichtungselement (110), welches dazu konfiguriert ist, eine sterile Barriere und/oder eine Dampfsperre zwischen einer inneren Umgebung des Gehäuses (104) und einer äußeren Umgebung des Gehäuses (104) zu bilden, wobei das Dichtungselement (110) eine abnehmbare Kappe umfasst, welche so konfiguriert ist, dass sie mit einem Abschnitt des Gehäuses (104) gekoppelt werden kann; und
    ein Stützelement (116), welches so konfiguriert ist, dass es zumindest eine seitliche Bewegung der Einführanordnung (118) verhindert, dadurch gekennzeichnet, dass
    die Einführanordnung (118) eine Nadel (140) umfasst, welche durch das Stützelement (116) verläuft.
  2. Applikator (100) nach Anspruch 1, wobei das Dichtungselement (110) von dem Applikator (100) lösbar ist.
  3. Applikator (100) nach Anspruch 1, weiter die Auf-der-Haut-Anordnung umfassend, und wobei die Auf-der-Haut-Anordnung (102) optional einen Sensor und/oder einen Sender und/oder eine Haftschicht umfasst, welche dazu konfiguriert ist, die Auf-der-Haut-Anordnung (102) auf der Haut des Patienten zu halten.
  4. Applikator (100) nach Anspruch 1, wobei das Stützelement (116) eine Elastomermembran, einen Film, ein Massenelastomer, Schaum oder eine starre Struktur umfasst.
  5. Applikator (100) nach einem vorstehenden Anspruch, weiter eine oder mehrere Rippen oder Vertiefungen, welche so konfiguriert sind, dass sie dem Patient eine taktile Griffanzeige bieten und/oder zumindest einen Vorsprung umfassend, welcher dazu konfiguriert ist, Rollen des Applikators (100) zu verhindern.
  6. Applikator (100) nach einem vorstehenden Anspruch, wobei der Applikator (100) eine Querschnittsform aufweist, welche konfiguriert ist, dem Patienten eine taktile Griffanzeige zu bieten.
  7. Applikator (100) nach Anspruch 1, wobei die abnehmbare Kappe so konfiguriert ist, dass sie mit einem proximalen Abschnitt des Gehäuses (104) gekoppelt werden kann, und/oder wobei die abnehmbare Kappe so konfiguriert ist, dass sie mit einem distalen Abschnitt des Gehäuses (104) gekoppelt werden kann, und/oder wobei die abnehmbare Kappe so konfiguriert ist, dass sie in einer einzelnen axialen Ausrichtung mit dem Gehäuse (104) gekoppelt werden kann, und/oder wobei die abnehmbare Kappe so konfiguriert ist, dass sie über ein Gewinde mit dem Abschnitt des Gehäuses (104) gekoppelt werden kann.
  8. Applikator (100) nach einem vorstehenden Anspruch, weiter einen Manipulationsindikator umfassend.
  9. Applikator (100) nach einem vorstehenden Anspruch, wobei das Dichtungselement (110) eine Schale umfasst, eine Ausrichtungsfunktion für die Auf-der-Haut-Anordnung (102) umfasst, wobei die Schale bevorzugt eine Nadelschutzfunktion umfasst.
  10. Applikator (100) nach einem vorstehenden Anspruch, wobei das Betätigungselement eine Kappe umfasst, welche mit einem proximalen Abschnitt des Gehäuses (104) gekoppelt ist.
  11. Applikator (100) nach einem vorstehenden Anspruch, wobei die Nadel so konfiguriert ist, dass sie aus der Einführanordnung (118) zurückgezogen werden kann, nachdem die Einführanordnung (118) die Auf-der-Haut-Anordnung (102) einführt.
  12. Applikator (100) nach einem vorstehenden Anspruch, wobei das Gehäuse (104) ein Einweggehäuse ist.
  13. Applikator (100) nach einem vorstehenden Anspruch, wobei das Stützelement (116) dazu konfiguriert ist, die Einführanordnung (118) bei schädlichen Bewegungen, beispielsweise einem Sturz oder einer Vibration, in Position zu halten.
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